Virtual Reality Mindfulness Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 主要终点
- Pain severity
研究概览
简要总结
This is an exploratory study investigating the use of virtual reality-based guided mindfulness meditation in improving pain, stress, and mood within various clinical populations. The feasibility of utilizing VR applications within the populations of patients with various specific disease types and clinical settings is a burgeoning area of research. The goal is to establish an association between the use of VR-based mindfulness meditation, and pain, stress, and mood scores.
详细描述
This is a two-center, multi-site exploratory study conducted within the University of California, Los Angeles Health and Greater Los Angeles VA systems. A total of 60 subjects will be recruited. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Subjects will undergo assessments of stress, depression, anxiety, and pain at baseline, pre- and post-VR guided mediation, and monthly for three months. Each subject can undergo VR-guided meditation session no more than one time per day. In subjects who are hospitalized, an attempt will be made to have the subjects undergo the VR meditation and complete the pre- and post- meditation assessments daily until hospital discharge.
Duration of the study is expected to be 1 year. Each session is expected to last approximately 15 minutes.
Subjects will be given instructions on proper use of the VR devices and how to start the guided meditation software. Once familiar with the device, participants will undergo a guided VR meditation using a commercial VR application. The meditation will last approximately 15 minutes. Prior to starting and on upon completion of each VR meditation session, participants' state pain, anxiety, depression, and stress will be assessed. For each participant enrolled, baseline and monthly assessments using the DASS-21 and PPI-SFI3a will be performed for three consecutive months
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults at least 18 years old
- •Able to read and understand English (Guided meditation software has not yet been translated to languages other than English)
排除标准
- •Age <18 years old
- •Unable to speak, read or understand English language
- •Blindness or severe hearing impairment
- •Any disability or neurological deficit that would impair subject from using the virtual reality console
- •Significant movement disorder
- •Vertigo and/or motion sickness
研究组 & 干预措施
Study Arm
干预措施: Virtual Reality Based Mindfulness meditation (Behavioral)
结局指标
主要结局
Pain severity
时间窗: 2 hours
Change in VAS-100 scores pre- and post-use of VR meditation application
Completion of VR Mindfulness Meditation Session
时间窗: 2 hours
Proportion of subjects able to complete VR meditation sessions
State Anxiety
时间窗: 2 hours
Change in STAI-6 scores pre- and post-use of VR meditation application
次要结局
- Depression(2 hours)
- Long term change in Pain severity(3 months)
- Hospital Length of Stay(4 months)
- Ease of use and acceptability(2 hours)
- Stress(2 hours)
- Long term change in Stress, Anxiety, and Depression(3 months)